sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbo
FDA device recall Z-0148-2023 · posted 2022-10-28 · Terminated
Recall details
- Recalling firm
- SenTec AG
- Reason for recall
- Weak skin adhesion.
- Action taken
- The firm issued a letter to its consignees on 08/22/2022 regarding below standard adhesion properties of the MARe-SF (Multisite Attachment Rings - for Sensitive, Fragile skin) product containing replacement product in the form of the premium product - the Patient Application Kit (PAK-SF) and the recommendation to discard the affected product.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LKD
- Quantity affected
- 17208 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-08-22
- Date posted
- 2022-10-28
- Date terminated
- 2026-05-26
- Location
- Therwil, Switzerland
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet (K151329) | Sentec AG | 2015-12-17 |